At Koneksa, we are focused on using new technologies to improve clinical research and drug development. We help leading life sciences companies and research hospitals remotely capture real-world data from patients. Our projects deploy digital health technologies such as FDA approved activity trackers, wearable vital sign monitors, and other emerging monitoring devices that collect data outside the clinical and laboratory setting. We are developing digital biomarkers that help our customers make faster decisions, often using smaller studies, with technologies that enhance the experience of the patients who participate. 

We're on a constant quest to improve the tools and endpoints that are used to get the right new therapies to patients who need them. Our experienced and diverse team challenges traditional development paradigms to work at the intersection of what some would consider competing forces—compliance and innovation. At Koneksa, we believe that science, technology, analytics, and agile learning experiences are primary drivers to develop patient-centric solutions that enable our customers to make faster decisions in clinical trials.

We are actively seeking to hire a Project Manager with relevant experience to help our clients design, implement, and execute their clinical studies. This successful candidate will support protocol design and development, preparation for ethical approvals, site training, configuration and deployment of software and devices, and ongoing management and oversight from kickoff through study close out.

The project manager will work alongside our current Technology,  Data Science, and client team members to ensure that our projects are successfully executed, including the management of project risks.  This role will also contribute to the implementation of department-wide process improvements.This role will report to the Director, Client Services.  This role may require periodic travel.

Responsibilities

• Serve as primary point-of-contact with client team, research site coordinators, and vendors to support all aspects of client study execution, including:

  • Project planning and timeline management 

  • Study requirements gathering - translating study protocol into technology requirements

  • Training and user management 

  • Inventory management / logistics

  • Lead, facilitate, and/or attend study team meetings

  • Scope and budget management

  • Study closeout activities

• Collaborate with functional areas within Koneksa to ensure timelines and client expectations are met within budget.

• Support software and device testing with both technology and data science teams prior to launch

• Engage with vendors supporting each study and oversight of study-specific vendor activities

• Work with our technology team to ensure study configurations meet client and protocol requirements

• Collaborate with client and internal Koneksa team on client project escalations from identification and assessment to resolution.

• Reporting of internal project status updates

• Other duties as assigned

• Bachelors’ degree or equivalent experience

• 3+ years of progressive professional experience

• 1-3 years of experience in project management, preferably in the planning and support of interventional pharmaceutical studies

• Knowledge of the US and/or international regulations governing human subject research for investigational new drugs

• Understanding of the software development life cycle and the configuration of software solutions

• Outstanding verbal and written communication skills

• Strong time management and organizational skills.  Able to manage multiple concurrent projects

• Understanding of the drug development process

• Strong interpersonal skills and ability to engage effectively with all levels of the organization

• Experience in issue management and stakeholder navigation

• Experience with smartsheet and/or other project management software

Bonus | Desirable Experience

• Experience with activity trackers / wearable devices/sensors

• Experience with Clinical Trial Management Systems / Electronic Data Capture

• MS Office Suite experience

• Experience within a software/technology company

Benefits

• Competitive salary
• Stock option scheme eligibility
• Comprehensive benefits package
• Employer 401(k) matching
• Choice of computer equipment

Koneksa Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Koneksa Health Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.